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WASHINGTON – Senate Finance Committee Ranking Member Ron Wyden, D-Ore., and senior committee member Chuck Grassley, R-Iowa, today released the results of an 18-month investigation into the pricing and marketing of Gilead Sciences’ Hepatitis C drug Sovaldi and its second-wave successor, Harvoni. Drawing from 20,000 pages of internal company documents, dozens of interviews with health care experts, and a trove of data from Medicaid programs in 50 states and the District of Columbia, the investigation found that the company pursued a marketing strategy and final wholesale price of Sovaldi – $1,000 per pill, or $84,000 for a single course of treatment – that it believed would maximize revenue. Building on that price, Harvoni was later introduced at $94,500. Fostering broad, affordable access was not a key consideration in the process of setting the wholesale prices.

In the 18 months following Sovaldi’s approval, Medicare spent nearly $8.2 billion before rebates on Sovaldi and Harvoni. Over that same span, Medicare’s monthly spending on Hepatitis C treatments increased more than six-fold. In 2014 alone, Medicare and Medicaid combined to spend more than $5 billion on Sovaldi and Harvoni before rebates. That total is projected to climb in 2015. Gilead’s recent financial statements show U.S. sales of Sovaldi and Harvoni, including through public programs and private payers, totaled $20.6 billion after rebates in the 21 months following Sovaldi’s introduction.

Senators Wyden and Grassley will hold a press conference today at 11:15 a.m. in the Senate Radio/TV Gallery, S-325, to discuss the investigation. Details are below, including a streaming feed for media unable to attend in person. Further resources are also online and additional findings from the investigation are below. Video of the press conference can be found here.

“Gilead pursued a calculated scheme for pricing and marketing its Hepatitis C drug based on one primary goal, maximizing revenue, regardless of the human consequences. There was no concrete evidence in emails, meeting minutes or presentations that basic financial matters such as R&D costs or the multi-billion dollar acquisition of Pharmasset, the drug’s first developer, factored into how Gilead set the price. Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead. If Gilead’s approach to pricing is the future of how blockbuster drugs are launched, it will cost billions and billions of dollars to treat just a fraction of patients,” Senator Wyden said. “America needs cures for cancer, Alzheimer’s, diabetes and HIV. If those cures are unaffordable and out of reach to millions who need them, Congress will not have met its responsibilities to the American people. I reject the idea that America has to choose between soaring, out-of-reach drug prices and one-size-fits-all government policies. Solving this challenge will take fresh, bipartisan thinking and political independence to bring people together.”

“The Finance Committee has tremendous responsibility in overseeing the federal programs paying for prescription drug coverage,” Senator Grassley said. “With that responsibility, the committee should know how the costs to the public programs and private insurance companies of a single innovative drug entering the market without competition can have major effects on which patients get the new drug and when. This report sheds light on one example of the pricing decisions made by one company with a new prescription medicine that entered the market without competition in high demand. This might be an example that received the most attention in some time, but it won’t be the last. I look forward to discussions with my colleagues and the public on the policy questions in the report. I encourage everyone to read the report for the level of detail into pricing strategy that we don’t often see.”

Additional major findings from the investigation include:

Gilead justified Sovaldi’s high price point based on price-per-cure: Documents acquired during the course of investigation illustrate that Gilead was aware it was in a position to create clear savings for payers, but chose to pursue a “regimen neutral” price justified by “cost-per-cure” calculations that resulted in greater revenue per treatment than previous direct acting anti-virals [see page 42]. Given the increased clinical efficacy of Sovaldi, Gilead believed that it was more than justified in using the cost-per-cure pricing model [37, 46].

Gilead set a high price for Sovaldi with an eye toward ensuring a future high price for Harvoni: The documentation reviewed shows that Gilead considered a number of factors in determining a price point for Sovaldi, including costs for the existing standard of care for Hepatitis C treatment and setting a high baseline for the next wave of drugs, such as Harvoni [32-58]. In documents obtained during the course of investigation, Gilead officials noted the “value capture opportunity is in Wave 1,” and “Wave 2 access will be enhanced with a high Wave 1 price.” It went on to say that “[a]t any price, access for Wave 2 improves as the price for Wave 1 is increased, suggesting that Wave 1 will set a price benchmark against which Wave 2 will ultimately be evaluated.” By elevating the price for the new standard of care set by Sovaldi, Gilead intended to raise the price floor for all future Hepatitis C treatments, including its follow-on drugs and those of its competitors [44].

Gilead underestimated the degree of access restrictions that it expected would result from its pricing decision: Gilead set a price as high as it thought the market would bear before significant access restrictions would be imposed [30]. Gilead’s analyses were ultimately incorrect on this point as many payers adopted substantial access restrictions at the final price of $84,000 [81-88, 96-98].

Despite significant access restrictions, Gilead refused to significantly lower the net price: When confronted with the widespread initiation of access restrictions [99-106], Gilead refused to offer substantial discounts and did not significantly modify its contracting strategy to improve patient access. For example, Gilead offered Medicaid programs supplemental rebates of up to 10 percent; however, its offer came with the precondition that states had to drop some or all of their access restrictions [106]. For states already facing a steep financial burden, accepting that precondition in most cases would have increased the budgetary impact rather than easing it [107]. Only five state Medicaid programs reached agreements with Gilead to receive supplemental rebates in 2014 [138].

The burdens on Medicare, Medicaid, and the Bureau of Prisons were significant: The price of Sovaldi constituted a large burden—notably among state Medicaid programs, Medicare, and the BOP—and triggered access restrictions across public and private payers, thus limiting the number of Hepatitis C-infected patients who could access the new treatment options [81-88, 96-98]. For example, state Medicaid programs nationwide spent $1.3 billion before rebates on the drug in 2014. Even with that expenditure, less than 2.4 percent of the roughly 700,000 Medicaid enrollees with Hepatitis C were treated with Sovaldi [82-87]

Competition entered the market, prices responded, but there are still significant concerns: Three days following Viekira Pak’s approval on December 19, 2014, Express Scripts Holding Co., the nation’s largest pharmacy benefit manager, announced that it would make Viekira Pak its preferred treatment for Hepatitis C genotype 1 and would no longer cover Sovaldi and Harvoni for these patients [112]. Gilead responded in January and February 2015 by entering into discounting agreements for Harvoni and Sovaldi with CVS, Anthem, Humana, Aetna, and UnitedHealth Group. Cigna struck agreements with Gilead for Harvoni only [113]. Even as competition lowered prices for therapies, this report documents that concerns remain, particularly in the public payer community, about high costs for treating millions of people in the U.S. infected with Hepatitis C, as well as the budgetary effects of a future single source innovator that might not face competition as quickly [114-122].